Updated OCEAN Results and Partial Clinical Development Hold - July 8, 2021

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Updated OCEAN Results and Partial Clinical Development Hold - July 8, 2021
Updated OCEAN Results and Partial Clinical Development Hold
July 8, 2021
Updated OCEAN Results and Partial Clinical Development Hold - July 8, 2021
Participants

                     Marty J Duvall            Klaas Bakker           Jakob Lindberg
                   Chief Executive Officer   Chief Medical Officer   Chief Scientific Officer

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Updated OCEAN Results and Partial Clinical Development Hold - July 8, 2021
Disclaimer

    IMPORTANT: You must read the following before continuing. The following applies to this document, the oral presentation of the information in this document by
    Oncopeptides AB (the “Company”) or any person on behalf of the Company, and any question-and-answer session that follows the oral presentation (collectively, the
    “Information”).
    On 26 February 2021, the U.S. Food and Drug Administration (“FDA”) approved PEPAXTO® (melphalan flufenamide, also known as melflufen), in combination with
    dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose
    disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. This indication has been granted
    under accelerated approval based upon data from the HORIZON study. Melflufen is not approved by any other registration authorities.
    Melflufen is an abbreviated form of the international non-proprietary name (INN) melphalan flufenamide
    The Information contains forward-looking statements. All statements other than statements of historical fact included in the Information are forward-looking statements.
    Forward-looking statements give the Company’s current expectations and projections relating to its financial condition, results of operations, plans, objectives, future
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    meaning or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Company’s
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    No representation, warranty or undertaking, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness
    of the Information or the opinions contained therein. The Information has not been independently verified and will not be updated. The Information, including but not
    limited to forward-looking statements, applies only as of the date of this document and is not intended to give any assurances as to future results. The Company
    expressly disclaims any obligation or undertaking to disseminate any updates or revisions to the Information, including any financial data or forward-looking statements,
    and will not publicly release any revisions it may make to the Information that may result from any change in the Company’s expectations, any change in events,
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    used in the Information not attributed to a specific source are estimates of the Company and have not been independently verified.

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Updated OCEAN Results and Partial Clinical Development Hold - July 8, 2021
Updated OCEAN result and partial clinical hold
    Key Takeaways
                                         • OCEAN result
                                           o IRC reassessment met superiority on primary
                                             endpoint of progression free survival across the ITT
                                             population
                                           o Mixed overall survival results
                                           o IMWG Meeting (September) targeted for full data
                                             disclosure

                                         • Clinical development
                                           o All trials are now placed on partial clinical hold

                                         • PEPAXTO commercialization
                                           o Continued marketing based on HORIZON label

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Updated OCEAN Results and Partial Clinical Development Hold - July 8, 2021
Label expansion opportunity with phase 3 OCEAN Study
    Confirmatory global study in 100+ sites in 21 countries

                                                Head-to-head study versus pomalidomide
       Patients have failed 2-4 lines                                                 Primary
                                            N = 495              Melflufen +
       prior therapy, including                                                      endpoint:
                                         Lenalidomide-         dexamethasone
       refractory to lenalidomide                                                       PFS
       within 18 months or have            refractory
       progressed on lenalidomide           multiple                                 Secondary
       within 60 days of randomization     myeloma             Pomalidomide +        endpoint:
                                            patients           dexamethasone          ORR, OS

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OCEAN Study – detailed timeline and upcoming events

                                                                            June 1
                                                             Analysis indicates that                                             March
                    June 14                                patients stay on treatment                                   Estimated primary
                 First patient                              longer than anticipated3                                    completion date4a
                   treated1
                                                        May 22                            September 4                                                                                                                      Expected
                                                      Enrollment                          OCEAN study                                                                                                                        sNDA
    EVENTS                                            complete2                          fully recruited7                                                                                                                 submission

             2017                           2020                                                               2021                                                                                                          2022
                                                                                                                                                                 May 25                                     Q3
    DATA                                                                                                                                                    Topline results                            Presentation of
                                                                                                                                                              disclosed                               primary data at a
    RELEASES                                                                                                                                                                                          select congressb

                                                  March
                                             Study design
                                                                                                                                                                                        July 8
                                             published in                                                                                                                       Final IRC results
                                           Future Oncology6                                                                                                                        disclosed

aEvent-driven; bCurrent assumption and plan .

1. Oncopeptides Press Release. June 14, 2017; 2. Oncopeptides Press Release. May 22, 2020; 3. Oncopeptides Press Release. June 01, 2020; 4. ClinicalTrials.gov Identifier: NCT03151811; 5. Sonneveld P,
et al. [Poster Presentation P-036] Lymphoma & Myeloma Congress 2019; 6. Schjesvold F, et al. Future Oncol. 2020;16:631–641. 7. Oncopeptides Press Release. Sep 4, 2020

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The path to a final IRC result on OCEAN

    • Topline result communicated on May 25
    • A finding that all available data in the clinical trial database had not been
      provided to the IRC at the time of assessment
    • Review conducted by CRO across all 495 patients which determined that
      29 patients needed reassessment
    • IRC performed a blinded reassessment of the 29 patients

    NOTE: There has been continuous and ongoing dialogue with the FDA through this process.

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OCEAN data – final IRC ITT results

    • Primary endpoint – Progression Free Survival (PFS)
                                              Hazard Ratio         P-Value        Relative mPFS   Outcome
                                                (95% CI)                          improvement
       Independent Review Committee (IRC)         0.792            0.0311             +39%        Superiority
                                              (0.640-0.979)

    • Overall Response Rate 32.5% for melflufen vs 26.9% for pomalidomide

      0          5          10          15       20           25             30          35

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OCEAN Data – overall survival data

    • OCEAN is the first head-to-head comparison of two different treatment modalities in MM
    • Striking efficacy differences were seen across different patient populations
    • Overall Survival Hazard Ratio was 1.104 in favor of pomalidomide for the ITT population
    • Large differences in pre-specified subgroups are currently undergoing investigation in
      collaboration with the FDA

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Clinical development program put on partial clinical hold

     • This decision immediately impacts all clinical studies including the following:
       o LIGHTHOUSE study
       o ANCHOR Study
       o PORT Study
       o BRIDGE Study
       o ASCENT Study
       o COAST Study (OPD5)
     • No new patients will be enrolled during the partial clinical hold effective immediately
     • Patients already enrolled in the studies may continue their treatment
       (subject to reconsent and assessment by the investigator)

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Updated OCEAN result and partial clinical hold
     Key Takeaways
                                          • OCEAN result
                                            o IRC reassessment met superiority on primary
                                              endpoint of progression free survival across the ITT
                                              population
                                            o Mixed overall survival results
                                            o IMWG Meeting (September) targeted for full data
                                              disclosure

                                          • Clinical development
                                            o All trials are now placed on partial clinical hold

                                          • PEPAXTO commercialization
                                            o Continued marketing based on HORIZON label

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